Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa|
- change in plasma viral load and time to ART initiation between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]change in plasma viral load and time to ART initiation between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months.
- change in genital tract HIV shedding (measured through viral load) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- IUD continuation rates between HIV-positive ART-naive women using the levonorgestrel IUD and those using the copper IUD over 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Copper T-380a IUD
Copper T-380a IUD
Device: Mirena levonorgestrel IUD
Intrauterine contraceptive devices
Active Comparator: Mirena Levonorgestrel IUD
Mirena levonorgestrel IUD
Device: Copper T-380a IUD
intrauterine contraceptive device
Design: Single site, double-blind, randomized controlled trial
Population: Antiretroviral therapy ineligible, HIV-positive South African women between the ages of 18 and 40 years
Study size: 324 women
Study intervention: Levonorgestrel intrauterine device (LNG IUD) or the copper T-380 intrauterine device (C-IUD)
Duration & Follow-up: Approximately 42 months in total. Recruitment will take approximately 18 months. After enrollment, each participant will be followed for 24 months.
Primary Objectives: To compare LNG IUD safety to the safety of the C-IUD by comparing HIV progression between the two study arms.
Secondary Objectives: 1) To measure LNG IUD safety with respect to genital viral load shedding, a surrogate for HIV infectivity, as compared to the C-IUD. 2) To measure LNG IUD acceptability through device continuation and other measures as compared to the C-IUD.
Primary Endpoints: HIV-1 Viral Load (VL) change, CD4 change, hemoglobin change, time to antiretroviral therapy (ART) initiation, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID)
Secondary Endpoints: 1) Initiation/acceleration of detectable HIV RNA genital shedding 2) IUD continuation and expulsion rates and acceptability measures through quantitative and qualitative methods
Study Site: Gugulethu Community Health Centre (GCHC), Cape Town, South Africa
|Contact: Catherine Todd, MD, MPHemail@example.com|
|University of Cape Town||Recruiting|
|Cape Town, Western Cape Province, South Africa, 7701|
|Contact: B Landon Myer, MBChC, PhD 01127214066661 Landon.Myer@uct.ac.za|
|Principal Investigator: B Landon Myer, MBChB, PhD|
|Principal Investigator:||B Landon Myer, MBChB, PhD||University of Cape Town|